Shilpa Medicare Hiring Regulatory Affairs (Formulation – US/EU/CA)
- About Shilpa Medicare Limited
- Key Responsibilities
- Required Qualifications
- Job Location
- How to Apply
- Why Join Shilpa Medicare?
- Courses Considered Under This Educational Background:
- Summary Table for SEO and Candidate Convenience
Regulatory Affairs Executive Jobs for B.Pharm/M.Pharm in Hyderabad | Shilpa Medicare
Apply for Regulatory Affairs Executive/Sr. Executive roles (Formulation – US/EU/CA) at Shilpa Medicare Limited, Hyderabad. B.Pharm/M.Pharm with 3-6 years experience preferred.
Exciting Opportunity for Regulatory Affairs Professionals in Formulation at Shilpa Medicare, Hyderabad
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📱 Join Click HereIf you are a motivated B.Pharm or M.Pharm graduate with 3–6 years of experience in regulatory affairs for US, EU, or Canada markets, Shilpa Medicare Limited invites you to apply for their Executive/Sr. Executive position based at Nacharam, Hyderabad. This is your chance to work with a well-established pharmaceutical firm focusing on complex regulatory submissions and global compliance.
About Shilpa Medicare Limited
Shilpa Medicare is a leading name in the global pharmaceutical sector with decades of experience in delivering quality healthcare solutions. The company is known for its focus on regulatory excellence, particularly in the USFDA, EMA, and Health Canada domains.
Key Responsibilities
Regulatory Strategy and Documentation
- Handle pre and post-approval activities for US/EU/CA regulatory submissions.
- Draft, compile, and publish eCTD dossiers.
- Review and compile CMC documentation and technical reports.
Compliance and Submissions
- Manage Annual Reports and Supplements submissions.
- Prepare Sterility Assurance Packages for injectable dossiers.
- Coordinate Pre-IND/scientific advice meeting packages.
Quality and Cross-Functional Support
- Evaluate regulatory authority deficiencies and create action plans.
- Review development documents and QMS documentation.
- Provide regulatory support to customers, including query resolution.
- Update cross-functional teams on regulatory requirements.
Labelling & Pharmacopoeial Compliance
- Review specifications and test procedures.
- Outline labelling, packaging, and storage requirements.
- Contribute to QBD (Quality by Design) and product development reports.
Required Qualifications
- Education: B.Pharm / M.Pharm (Pharmacy)
- Experience: 3 to 6 years in regulatory affairs (Formulation)
- Skills: Strong exposure to USFDA, EMA, Health Canada compliance, eCTD publishing, injectables & solid orals regulatory work.
Job Location
Nacharam, Hyderabad, India
How to Apply
Send your updated CV directly to:
Make sure to include:
- Total years of experience
- Current and expected CTC
- Notice period
Why Join Shilpa Medicare?
- Be part of a globally recognized, regulatory-focused team.
- Gain exposure to diverse markets including US, EU, and Canada.
- Opportunity to grow in a fast-paced, compliance-driven environment.
Courses Considered Under This Educational Background:
- Bachelor of Pharmacy (B.Pharm)
- Master of Pharmacy (M.Pharm)
- Pharmaceutical Regulatory Affairs Certification
Summary Table for SEO and Candidate Convenience
| Company Name | Current Vacancies in Departments | Required Education | Experience Required |
|---|---|---|---|
| Shilpa Medicare Limited | Regulatory Affairs (Formulation – US/EU/CA) | B.Pharm / M.Pharm | 3 to 6 years |
